Stevens-Johnson Syndrome from Acetaminophen: Really?

On August 1, 2013, the FDA issued a Safety Announcement informing the public that acetaminophen (Tylenol), which is called paracetamol in the UK, has been associated with Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. And no one noticed that before? I guess that’s possible. Even after 50 years of near-universal use, it was not generally appreciated that aspirin could cause bleeding. And it took decades before anyone realized that tetracycline mottled the teeth of young children.

Of course some people who developed Stevens-Johnson syndrome had taken acetaminophen, since more or less everyone takes acetaminophen from time to time. Such cases have been reported to the FDA and have been described in the literature, but what is the evidence for causality? The FDA cites 3 case reports published in 1998, 2000 and 2010 (in Acta Derm Venereol, Ann Pharmacother and Allergol Immunopathol [Madrid], respectively) in which the patients were rechallenged with acetaminophen and had a recurrence of a serious skin reaction. Three patients. With a denominator that is probably in the trillions.

As a result, the FDA will require that a warning be added to all prescription products containing acetaminophen and request that manufacturers of OTC acetaminophen products do the same. I am not sure about the epidemiology here, but I know courage when I see it.

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Comments

  1. The FDA did some very interesting things with colchicine and thyroid hormone. Perhaps they have it in mind to make APAP a prescription drug only, repackage it, and grant market exclusivity to a company that charges $5 per pill for it.

    If they are going to warn about APAP at all, I think it should be to remind people that high doses of it will cause liver failure and slow death. It is not a fast painless death. That may dissuade some depressed people from using it as a means of suicide.

    I have been taking many of the comments from the FDA with a grain of salt lately. The days of muckraking and picking the low fruit like bad beef and narcotics in cola are gone (I hope). In order to make it seem they are worth their budget they do things like this.

    If my taxes are paying for this, I want better. I don’t think a study on the extremely rare instance of SJS and APAP was paid for by a pharmaceutical company. If that is where my taxes go, then FDA needs to be made smaller and more efficient.

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